Redx Pharma gets regulator backing to re-start cancer treatment trial

StockMarketWire.com - Cancer and fibrosis drug development company Redx Pharma said regulators had backed a proposed re-start of a trial of its porcupine inhibitor-based tumor treatment.

The company said it had presented an amended study protocol to the Medicines and Healthcare products Regulatory Agency.

The agency had subsequently agreed, in principle, with the proposed re-start of the company's so-called phase 1/2a clinical study for the porcupine inhibitor, RXC004.

Redx said it would now work with the investigators to finalise the protocol, with the intention of restarting dosing of patients in the first half of 2019.

'Based on a thorough analysis of the data from the only patient in the currently suspended trial, Redx, together with the study investigators, believe that the desired systemic exposure ... can now be achieved using a significantly lower starting dose, with subsequent dose-escalation,' the company said.

'Following a positive meeting with the company, the MHRA has agreed, in principle, with this newly proposed starting dose and revised protocol, including enhanced safety monitoring.'

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